NDC 78314-101 Sanitary Wet Wipes

Sanitary Wet Wipes

NDC Product Code 78314-101

NDC 78314-101-01

Package Description: 1 CLOTH in 1 BAG

NDC Product Information

Sanitary Wet Wipes with NDC 78314-101 is a a human over the counter drug product labeled by Wenzhou Chuangying Daily Necessities Co., Ltd. The generic name of Sanitary Wet Wipes is sanitary wet wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Wenzhou Chuangying Daily Necessities Co., Ltd

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sanitary Wet Wipes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALCOHOL 1.75 mL/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • WATER (UNII: 059QF0KO0R)
  • POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wenzhou Chuangying Daily Necessities Co., Ltd
Labeler Code: 78314
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sanitary Wet Wipes Product Label Images

Sanitary Wet Wipes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic.

When Using

Avoid contact with eyes and wound.Be careful not to enter eyes.If it gets into eyes accidentally, please wash it with plenty of water.

Do Not Use

It cannot be used for infants less than 2 months old.

Stop Use

Stop use if irritation and redness develop. If condition continues, consult your health care practitioner.

Keep Out Of Reach Of Children

Keep out of reach of the children.

Indications & Usage

This product is suitable for wiping hands, face, skin, etc.

Directions

Apply appropriate amount of the product to the palm, rub, let stand and dry.

Warnings

For external use only.Flammable, please stay away from fire or heat.

Other Information

Store in cool and dry place.Keep away from direct sunlight and fire.

Inactive Ingredient

Polyhexamethylene biguanide Hydrochloride (PHMB), Benzalkonium chloride (BAC), Water.

* Please review the disclaimer below.